UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062197 |
|---|---|
| Receipt number | R000071176 |
| Scientific Title | Short-term ubiquinol supplementation on exercise performance and heart rate in male collegiate distance runners: A randomized, parallel-group, placebo-controlled trial |
| Date of disclosure of the study information | 2026/07/10 |
| Last modified on | 2026/07/10 10:25:23 |
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Basic information
Public title
Short-term ubiquinol supplementation on exercise performance and heart rate
Acronym
Short-term ubiquinol supplementation on exercise performance and heart rate
Scientific Title
Short-term ubiquinol supplementation on exercise performance and heart rate in male collegiate distance runners: A randomized, parallel-group, placebo-controlled trial
Scientific Title:Acronym
Short-term ubiquinol supplementation on exercise performance and heart rate in male collegiate distance runners: A randomized, parallel-group, placebo-controlled trial
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the effect of short-term ubiquinol supplementation on exercise performance and heart rate in male collegiate distance runners.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Exercise performance
Heart rate
Key secondary outcomes
Blood biochemical parameters
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
300 mg/d Ubiquinol, 1 week
Interventions/Control_2
Placebo, 1 week
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
1. 16 healthy male college long-distance track and field athletes
2. Aged 18 to 25
3. Individuals in good physical condition who can safely participate in the test
4. Individuals who, prior to participating in this test, have received an explanation of the test, understand its content, and agree with its purpose
5. Individuals from whom written consent can be obtained
Key exclusion criteria
1. Individuals currently receiving medical treatment or prescription medication
2. Individuals suffering from, or with a history of, severe cardiovascular, hepatic, renal, respiratory, endocrine, or metabolic disorders
3. Individuals at risk of developing an allergy related to the test diet
4. Individuals who regularly take supplements containing coenzyme Q10
5. Individuals who smoke
6. Individuals who have donated blood (e.g., as a blood donor) in an amount exceeding 200 mL within 1 month prior to the start of this trial, or 400 mL within 3 months prior to the start of this trial
7. Individuals who have participated in another clinical trial within the past 3 months, or who are currently participating in another clinical trial
8. Any other individuals deemed ineligible by the principal investigator
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Suzuki |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1 Hirakagakuendai, Inzai, Chiba, Japan
TEL
+81-476-98-1001
yssuzuki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Suzuki |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
2701695
Address
1-1 Hirakagakuendai, Inzai, Chiba, Japan
TEL
0476981001
Homepage URL
yssuzuki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University,
Graduate School of Health and Sports Science
Institute
Department
Personal name
Funding Source
Organization
Kaneka Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee, Juntendo University, Graduate School of Health and Sports Science
Address
1-1 Hirakagakuendai, Inzai, Chiba, Japan
Tel
0476-98-1001
sc-gradkyomu@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
https://docs.google.com/document/d/1aJqRru2gCRwNpOaWj3ecSVCna9xy6Jif9sPVDE2XLf8/edit?usp=sharing
Publication of results
Unpublished
Result
URL related to results and publications
https://docs.google.com/document/d/1aJqRru2gCRwNpOaWj3ecSVCna9xy6Jif9sPVDE2XLf8/edit?usp=sharing
Number of participants that the trial has enrolled
16
Results
Plasma reduced, oxidized, total CoQ10, and reduced form % increased significantly in CoQ10 group (p<0.001). No significant changes were found in blood markers or cycling performance in either group. Notably, at 30s post-exercise after the 15-min incremental test, CoQ10 group showed significant improvements in absolute HR recovery and HR recovery ratio (p<0.01, p<0.001), while no significant changes occurred at 60s and 300s.
Results date posted
| 2026 | Year | 07 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 16 healthy male collegiate distance runners completed the study (Placebo group: n = 8, CoQ10 group: n = 8). Exclusion criteria were: (1) current smoking; (2) weight loss of >=5% within 3 months prior to enrollment; (3) a history of severe cardiovascular, hepatic, renal, respiratory, endocrine, or metabolic disease; (4) participation in another clinical trial within 3 months prior to study entry; and (5) any dietary restrictions within the preceding weeks. Baseline characteristics (Mean +/- SD) showed no significant differences between the two groups:
- Age: Placebo 20.4 +/- 1.2 years vs. CoQ10 20.5 +/- 1.3 years
- Height: Placebo 170.9 +/- 5.0 cm vs. CoQ10 170.1 +/- 4.9 cm
- Weight: Placebo 56.9 +/- 4.7 kg vs. CoQ10 58.5 +/- 5.1 kg
Among blood biochemical markers, LDL-C was significantly lower in the CoQ10 group than in the placebo group at baseline (p < 0.05).
Participant flow
- Enrollment & Allocation: 16 participants were assessed for eligibility and randomized into the Placebo group (n = 8) or the CoQ10 group (n = 8).
- Intervention: All 16 participants (n = 8 per group) successfully completed the 1-week intervention.
- Analysis: All 16 participants (n = 8 per group) were analyzed for the primary outcomes (blood biochemical markers and exercise performance). However, due to missing data caused by technical issues during heart rate monitoring, 1 participant from the placebo group and 3 participants from the CoQ10 group were excluded from the heart rate recovery sub-analysis. Consequently, the heart rate recovery analysis was limited to 12 participants (Placebo, n = 7; CoQ10, n = 5).
Adverse events
No clinically meaningful adverse events or adverse changes were observed or reported during the 1-week intervention period. Most biochemical parameters related to muscle damage, liver function, renal function, or iron metabolism remained within their respective normal ranges, and no clinically meaningful adverse changes were observed in either group.
Outcome measures
1. Exercise performance metrics, including peak cadence and mean power during the 30-second full-power test, and mean power at each stage and total power output during the 15-minute incremental cycling test.
2. Post-exercise heart rate recovery (HRR) and HRR ratio assessed at 30, 60, and 300 seconds following the 15-minute incremental cycling test.
3. Changes in plasma coenzyme Q10 concentrations (reduced form, oxidized form, total CoQ10, and the percentage of the reduced form) from pre- to post-intervention.
4. Changes in blood biochemical markers (CK, Mb, AST, ALT, LDH, gamma-GTP, ALP, Cre, BUN, UA, TC, LDL-C, Fe, Ferritin, TSAT, TIBC, and UIBC) from pre- to post-intervention.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 10 | Day |
Last modified on
| 2026 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071176
